1. NUTRITION CONTROVERSIES: How to handle the tough questions and separate facts from emotion Keith-Thomas Ayoob, EdD, RD, FADA, CDN Associate Clinical Professor of Pediatrics Albert Einstein College of Medicine School Nutrition Association Legislative Action Conference March 1, 2010

2. 4 examples of risky topics Food allergies Sugar Artificial colors Sugar substitutes

3. Common thoughts… Change the menu, my kid is allergic Sugar is making kids Fat Hyperactive Diabetic High

4. More common thoughts… Artificial colors make them hyperactive Sugar substitutes… Cause brain tumors/cancer/liver problems Turn into formaldehyde in your body Make you crave sweets Just HAVE to be bad – I read it on the Internet

5. OK, who doesnt eat what? Food Allergies

6. THE BIG 8 Peanuts Eggs Shellfish Fish Milk Wheat Soy Tree nuts

7. THE BIG 8 Account for 80% of allergies Most kids outgrow food allergies Most are NOT life-threatening

8. Problems with special diets: Labor intensive Costly May affect very few Many varieties Most not life-threatening

9. Special diets: Time to put our foot down? First it was allergies Then peanut-free tables/schools/lives Limits of reasonable responsibility Budgets, budgets, budgets Rethinking the purpose of school lunch

10. GO TO HILL! Tell your legislators: We do school lunch, not hospital lunch Opt-out when below national average Optional accommodation, based on budget or other considerations Rally against forcing schools to outlaw allergic foods

11. A R T I F I C I A L C O L O R S

12. What ARE they? Regulated by FDA 2 kinds of colors in food: Certified color additives Colors exempt from certification

13. 9 Certified colors Blue #1 Blue #2 Green #3 Red #2 Red #3 Red #40 Orange B Yellow #5 Yellow #6

14. Exempt colors Naturally derived but are still color additives, must comply with regulations More expensive May impart flavors

15. What are they doing in our food? Compensate for color losses Maintain uniformity when colors naturally vary Enhance naturally occurring colors Give color to colorless foods

16. THE BIG QUESTION: DO COLORS IN FOOD CAUSE HYPERACTIVITY?

17. HISTORY Started with Feingold in the 1970s Hyperactivity caused by: Salicylates Artificial flavors Artificial colors Feingold, BF Delaware Med J 1977

18. Feingold phenomenon Early studies were highly criticized: Lack of controls Small sample sizes Anecdotal reports Inability to link specific colors with behavior Inconsistent dosing poor methodology lack of subjectivity …however……….. Feingold, BF Delaware Med J 1977

19. Review by Shab & Trinh (2004) Meta-analysis 15 DB-PC trials Results: 5 studies: increased ADHD symptoms 8 studies: no significant increases in ADHD symptoms 2 studies: DECREASED ADHD symptoms Only 2 trials received the highest validity score of A

20. Shab & Trinh (2004) 8 crossover studies Some effect seen in previously diagnosed hyperactive children BUT Serious flaws in many studies 2 had no washout period 3 had unorthodox outcome measures None had a validity rating of A One had imperfect blinding

21. Problems with studies on ACs and hyperactivity Whos doing the ratings? Does the test ask all the right questions? Include/exclude children on medication? Include/exclude non-hyperactive children? Include a washout period?

22. Bateman et al (2004) Randomized, DB-PC crossover trial 277 4-year-olds 20-mg of colors + 45 mg of sodium benzoate Ratings by parents AND teachers

23. Bateman et al (2004) Teacher ratings of hyperactivity: No behavioral difference between placebo and AC periods Parent ratings: Hyperactivity noted with BOTH placebo and AC periods Slightly greater with AC

24. Bateman et al (2004) Authors concluded: Some effect detectable by parents but not by typical clinic setting Weaknesses: Teachers saw no changes in classroom settings Parents saw more hyperactivity even with placebo. AC and Na benzoate mixed – unclear which component would explain results No dose response

25. McCann et al (2007) 3 yo8/9 yoComposition N =153144 Mix A20 mg AC25 mg AC4 AC + Na benzoate Mix B30 mg AC62 mg AC4 AC + Na benzoate General population Double-blind, placebo-controlled Global hyperactivity aggregate scores

26. McCann et al (2007) Comparing Mix A against placebo, Mix B against placebo: 3 y.o.: in both cases, Mix showed significantly greater hyperactivity scores 8/9 y.o.: in both cases, Mix showed significantly greater hyperactivity scores …but….

27. McCann et al (2007) When adjusted for: Week during trial Sex Maternal education SES GHA in baseline week Pretrial diet………

28. McCann et al (2007) Effect in 8/9 y.o., was significant only at highest dose (Mix B) Effect in 3 y.o. was significant only at the lower dose (Mix A).

29. McCann et al (2007) Among authors conclusions: …substantial individual differences in the response of children to the additives.

30. Conclusions of EFSA panel Mixes make it impossible to know effects/lack thereof of individual colors Inconsistency in results re: age, sex, type of observer www.efsa.europa.eu

31. Conclusions of EFSA panel …the study provides limited evidence that the two mixtures had a small and statistically significant effect on activity and attention. They also concluded that the McCann study did not provide an acceptable basis for altering the ADI for colors. EFSA Journal, 2008

32. Guidance Perceived or real, some subset of children may be especially sensitive or high- responders to ACs Look at quantity/frequency 4 oz. of candy for a 3-year-old and 8 oz. of candy for an 8-y.o. is EXCESSIVE Smaller amounts may matter little or none Assess context, setting, situation

33. Guidance Most ACs appear in treat foods & soda. Focus on limiting treats and intake of ACs will decline Diet quality may improve Only applies to Certified colors – exempt colors are not implicated

34. SUGAR

35. The buzz Sugar gets kids hyperactive Sugar makes kids overweight HFCS: The new trans fat. It gives you diabetes, metabolic syndrome, etc. Fructose causes high blood pressure.

36. How much sugar do we eat? Total added sugars eaten, per capita 1 : 1999: 107.7 lb. 2007: 97.0 lb. (=120 gm/day) 1 - ers.usda.gov, accessed 9/21/09

37. NHANES 2001-02 Sources of All Simple Sugars Present in Childrens Diets Fruits, 13.3% Vegetables, 2.1% (15.4%) Milk, milk products, 22.2% Meat, poultry, fish and mixtures, 1.4% All other grain products, 5.5% (29.1%) Cakes, cookies, pies and pastries, 8.2% Sugars and sweets including candy, 11.9% Carbonated soft drinks, 16.8% Fruitades and other beverages, 12.6% (49.5%) RTE cereals, 5.1% Misc. = 0.9 Source: Bell Institute for Health & Nutrition

38. What kind are we getting? www.ers.usda.gov, 2009

39. HFCS: the evil of the moment 2 basic kinds: HFCS 42: 42% fructose HFCS 55: 55% fructose Cane sugar (sucrose): 50% fructose Take-away message: HFCS is really not high in fructose

40. What IS high in fructose: Apple juice: 65% fructose, 35% glucose Pear juice: 74% fructose, 26% glucose

41. Sugar, HFCS, and obesity? Evidence suggests otherwise IOM report (2002): Higher intakes of sugar are associated with lower rates of obesity No clear and consistent association between increased intake of added sugars and BMI.

42. Sugar & HFCS and obesity -- NOT Inverse relationship found between sugar intake and bodyweight or BMI: Saris (2003) Hill & Prentice (1995) Inverse relationship between total sugar intake and total fat intake: Gibson (1996)

43. Sucrose and weight loss, satiety 42 women – two groups All on low-fat, low calorie diets 1 group consumed 43% of energy as sugar Result: No differences in weight loss, mood, hunger, stress level Equal decreases in BP, %BF, plasma lipids Surwit, AJCN 1997

44. Sugar & hyperactivity: How the rumors started Case study of 1 child by Crook (1974) Sugar was removed, behavior improved Controlled studies unable to replicate results

45. Sugar and behavior Negative associations generally dismissed by the scientific community 1 Perception of sugar by parents and consumers continues to defy years of sound science and logic. Some evidence that behavior is positively affected by sugar. 1 – IOM, Dietary carb, 2002

46. Meta-analysis by Wolraich, et al (1995) 23 studies Double blinded, placebo-controlled Known quantity of sugar Reported statistics useful for computing dependent measures

47. Meta-analysis by Wolraich, et al (1995) Conclusion: Sugar does not affect the behavior or cognitive performance of children. The strong belief of parents may be due to expectancy and common association. In fact…….

48. Sugar can even IMPROVE behavior and performance Decrease in activity after sucrose 1 or glucose 2 Sugar-containing snack can enhance ability to stay on task 3 Glucose enhances long-term verbal and spatial memory 4 1 – Behar et al (1994); 2- Saravis et al (1990) 3 – Busch et al (2002); 4- Sunram-Lea et al (2001) But….

49. How much is too much? 2005 DGA allow for added sugars and fats Discretionary calories include BOTH sugar and fat and assume that both are consumed Dietary Guidelines for Americans 2005

50. 2005 DGA: Discretionary calories 1400 cal/d2000 cal/d2400 cal/d Total DC171 cal267 cal362 cal From fat14 g18 g22 g From sugar16 g32 g48 g Ref: 2005 US Dietary Guidelines for Americans

51. The sugar shake-down Sugars not angel food but its not devils food either It does NOT get kids hyper More likely to be situational Not a matter of good or bad but how much and how often

52. Recommendations Spend wisely Quantity matters, frequency matters Type of sugar doesnt matter Most kids need to reduce their added sugar intake WONT make kids hyperactive! Dietary Guidelines for Americans 2005

53. AAP Policy Statement: Prevention of pediatric overweight & obesity Dietary practices should be fostered that encourage moderation rather than overconsumption, emphasizing healthful choices rather than restrictive eating patterns.

54. AAP Policy Statement: Soft drinks in schools Each 12-oz sugared soft drink consumed daily has been associated with a 0.18-point increase in a childs BMI and a 60% increase in risk of obesity, associations not found with "diet" (sugar-free) soft drinks. Sugar-free soft drinks constitute only 14% of the adolescent soft drink market. American Academy of Pediatrics, 2004

55. BOTTOM LINE Sugars OK Not too much Mostly fruit

59. IOM Report on School Meals Safe for all ages One of the most rigorously tested ingredients in the U.S. food supply Cant use it until high school

60. Where were getting our sugar subs: 2006* Application% of Total by Weight Beverages57.7 Tabletop sweeteners12.1 Personal care products11.8 Food 9.1 Other 9.3 * Based on low calorie sweetener sales to the processed food and beverage industry. SRI Consulting Chemical Handbook. 2007

61. Aspartame: Product History Approved in 1981 180-200 times sweeter than sucrose In more than 6,000 products and is consumed by over 200 million people globally, including: One of the most rigorously tested ingredients in the U.S. food supply www.aboutaspartame.com

62. Aspartame: Metabolism & Excretion Aspartame is metabolized to 3 (and ONLY 3) common dietary components: Aspartic acid Phenylalanine Methanol Absorption and metabolism of constituents the same whether derived from aspartame or other food products* *Stegink et al. The Clinical Evaluation of a Food Additive. New York, NY. CRC Press; 1996.

63. PHE Content of Aspartame-Sweetened Beverage Compared with Common Foods (in mg) 90 606 1059 332 934

64. Methanol in Aspartame-sweetened Beverage vs. Common Foods (mg) (Wucherphennig et al. Flussuges Obst. 348-354, 1853).

65. Acceptable Daily Intake: ADI for Aspartame: 50 mg/kg bw/day Consumption by high consumers (90 th percentile in the general population, including children), is between 5-10% of the ADI** Diabetics average 6.6%** *Renwick, A. G. (2006) The intake of intense sweeteners-An update review. Food Additives and Contaminants 4: 327-338. ** J Am Diet Assoc. 2004; 104:255-275.

66. Some of the safety concerns listed on the Internet Possibility of toxicity from methanol Elevations in plasma concentrations of phenylalanine and aspartic acid (altering brains neurochemical composition) Possibility of neuroendocrine changes Possible carcinogenic risk Postulated link with epilepsy and brain tumors Allegations of ailments from infertility to baldness

67. Highlights of Global Safety Confirmation Over 500 toxicological and clinical studies conducted over 30 years confirm safety Regulatory authorities in more than 100 countries have approved aspartame for use: European Food Safety Authority (EFSA) Re-Confirms Safety of Aspartame (May 2006) Scientific Committee on Food (SCF) of European Commission Reconfirms Aspartames Clean Bill of Health-(December 2002) U.K. Food Standards Agency supports conclusions of SCF- (December 2002) French Food Safety Agency Supports Safety of Aspartame-(May 2002)

68. Highlights of Global Safety Confirmation Regulatory authorities in more than 100 countries have approved aspartame for use: Health Canada Reaffirms Aspartames Safety- (February 2003) Joint Expert Committee on Food Additives of the WHO concluded that Aspartame is safe The UNs Food and Agricultural Organization (FAO) has concluded that Aspartame is safe

69. Safety Confirmation: USA American Diabetes Association American Dental Association ADA Position Paper, Use of Nutritive and Non- Nutritive Sweeteners American Medical Association Council on Scientific Affairs American Academy of Pediatrics, Committee on Nutrition American Cancer Society

70. Assessed Across Many Subgroups

71. 2007 Expert Panel on Aspartame Goal = convene an independent international panel of toxicology experts to review all scientific studies and assess the safety of current consumption of aspartame. Blinded study with Ajinomoto funding: Panelists identity unknown (each side); no conflicts of interest or contact with company Experts: Food toxicology, metabolism, carcinogenesis, pathology, neurotoxicology, epidemiology, toxicology of methanol & formaldehyde Panel spent 11 months reviewing > 500 scientific articles and reports on aspartame from over the past 30 years NHANES data to determine how much aspartame consumed by average person Magnuson Aspartame: A safety evaluation based on current use levels, regulations, and toxicological and epidemiological studies. Critical Reviews in Toxicology. 2007. 37(8):629-727.

72. Expert Panel Findings- Safe across Population Groups No credible evidence aspartame is carcinogenic or has any cancer-causing properties Extensive human studies: No link to memory loss, learning problems or any other neurological effects No effect on behavior, brain function or seizures in any of the groups studied No adverse effects on reproduction or lactation Safe for use by people with diabetes and may help them adhere to a lower-carbohydrate diet program to better control blood sugars Magnuson Aspartame: A safety evaluation based on current use levels, regulations, and toxicological and epidemiological studies. Critical Reviews in Toxicology. 2007. 37(8):629-727.

73. The Ramazzini Study Largest (and worst) animal study ever done on Aspartame. 1,800 (male and female) 8 wk old rats Very low to very high concentrations: Statistically significant dose-related increase in lymphomas and leukemias in females No significant increase in brain tumors Soffriti et. al. Aspartame induces lymphomas and leukemias in rats. Eur. J. Oncol., vol. 10, no. 2, pp. 108-116.

75. The Ramazzini Study: International Response Study widely criticized by experts due to numerous flaws in design, implementation and data reporting Conflicts with large body of credible studies thoroughly reviewed by regulatory authorities around the world Not a single regulatory body endorsed findings; cite large database of credible evidence showing absence of a carcinogenic effect Design and execution did not follow international protocol for animal carcinogenicity studies (or that of the National Toxicology Program) UK Committee on Carcinogenicity of Chemicals in Food criticized study design: statistical approach used did not fully adjust for age- related effects Would not provide access by outside pathologists to analyze all of the tissue samples where cancerous tumors were found (standard practice)

76. 2006 NIH/NCI Research Conducted independently of any funding or ties to industry groups Subjects included 556,990 men and women Five years of follow up -1995-2005 Lim et al. Prospective study of aspartame-containing beverages and risk of hematopoietic and brain cancers, Cancer Epidemiol Biomarkers Prev 2006;15(9). September 2006

77. 2006 NIH/NCI Research Results Increasing consumption NOT ASSOCIATED with any risk of cancer NO ASSOCIATION with subtypes of cancers reported in the Ramazzini study Lim et al. Prospective study of aspartame-containing beverages and risk of hematopoietic and brain cancers, Cancer Epidemiol Biomarkers Prev 2006;15(9). September 2006

78. Aspartame & better diet quality Reported Use of Reduced-Sugar Foods and Beverages Reflects High-Quality Diets Reduced-sugar food users consistently reported significantly higher intakes of fruit, similar or higher micronutrient intakes, lower energy intakes and lower intake of discretionary fat and added sugars. -J Food Sci. Vol. 70, Nr.1, 2005, S42-S46.

79. So… Going forward, there are challenges…

80. The challenge Acknowledge theres difference between philosophy/ideology and sound science Provide the facts about high-emotion topics, based info on SOUND science Advocate for science-based legislation!

81. Working THE HILL… Parents/elected officials/constituents are under no obligation to adhere to sound science. WE are. Lobby for legislation WITH FUNDING